The Relationship Between Diaphragm Muscle Thickness and Fibromyalgia

NCT06396949 | Completed

• 1 other identifier: 97
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Fibromyalgia syndrome is characterized by chronic pain, fatigue, sleep problems and functional symptoms. Fatigue, anxiety and depression disorders, poor quality of life, sleep disorders, decreased concentration, and impaired cognitive functions are non-specific pain-related symptoms. Various studies have reported decreased chest expansion, maximal ventilatory volume and maximal expiratory pressure in fibromyalgia patients with widespread body pain. Additionally, dyspnea is a symptom associated with respiratory muscle weakness and is associated with general fatigue. In these individuals, lower data are obtained in daily living activities and general health evaluation surveys. We did not find any study in the literature regarding the relationship between diaphragm thickness and fibromyalgia symptoms. In the light of these data, we aimed to evaluate the thickness of the diaphragm, one of the most important inspiratory muscles, in fibromyalgia patients.

Conditions

Fibromyalgia; Anxiety; Depression; Diaphragm Issues

Keywords

Diaphragm thickness; Activities of daily living

Outcome Measures

Primary Outcomes (6)

• Fibromyalgia study form

  Fibromyalgia study form, consisting of clinical measurement (2016 ACR (American College of Rheumatology) fibromyalgia diagnostic criteria, Fibromyalgia impact questionnaire (FIQ), Beck Anxiety Questionnaire and Beck Depression Questionnaire, Short-Form (SF)-36), who applied to the outpatient clinic with fibromyalgia will be filled in detail.

  Within 1 month of applying to the outpatient clinic

• Pulmonary function test

  The investigators will use handheld spirometry device for measurement. Three measurements will be made. In these three measurements; FEV1(Forced Expiratory Volume In One Second)(L), FEV1 (%predicted), FVC (Forced Vital Capacity) (L), FVC (%predicted), FEV1/FVC (%) and FEV1/FVC (%predicted) will be evaluated. The arithmetic average of the results of these three measurements will be taken.

  Within 1 month of applying to the outpatient clinic

• Ultrasonographic Diaphragm Thickness Measurement

  Diaphragm thickness (millimeter-mm) will be measured in the supine position with a 6-14 Mhz lineer, conventional ultrasound probe (Mindray DC-8, Shenzen Mindray Bio-Medical Electronics CO. LTD.,P.R. China) at the end of inspiration and expiration from the intercostal space on the anterior axillary line. The measurements will be evaluated by making three measurements from the right 8-9. intercostal space where the diaphragm is best visualized. End-expiratory (Forced residual capacity-FRC) (millimeter-mm), end-inspiratory (Total Lung Capacity) (millimeter-mm) and thickening rate (%) (thickness TLC / thickness FRC) (percentage) will be evaluated three times and the arithmetic average of these three measurements will be taken.

  Within 1 month of applying to the outpatient clinic

• Fibromyalgia diagnostic criteria

  2016 revised American College of Rheumatology fibromyalgia diagnostic criteria; A patient satisfies the modified 2016 fibromyalgia criteria if the following three conditions are met: 1\. Widespread pain index (WPI) ≥7 and symptom severity scale (SSS) score ≥5, or WPI of 4∼6 and SSS score ≥9. 2. Generalized pain, defined as pain in at least four of five regions, must be present. Jaw, chest, and abdominal pain are excluded from the generalized pain definition. 3. Symptoms have been generally present for at least 3 months. 4. A diagnosis of fibromyalgia is valid irrespective of other diagnoses. A diagnosis of fibromyalgia does not exclude the presence of other clinically important illnesses.

  Within 1 month of applying to the outpatient clinic

• Fibromyalgia diagnostic criteria-Widespread pain index (WPI)

  Ascertainment 1\. WPI: note the number of areas in which the patient has had pain over the past week. In how many areas has the patient had pain? Score will be between 0 and 19 (Region 1) (Left upper region); jaw, left shoulder girdle, left upper arm, left lower arm, (Region 2) (Right upper region); jaw, right shoulder girdle, right upper arm, right lower arm, (Region 3) (Left lower region); hip (buttock, trochanter), left upper leg, left lower leg, (Region 4) (Right lower region); hip (buttock, trochanter), right upper leg, right lower leg and (Region 5) (Axial region); neck, upper back, lower back, chest, abdomen

  Within 1 month of applying to the outpatient clinic

• Fibromyalgia diagnostic criteria-Symptom severity scale (SSS)

  2\. SSS score Fatigue Waking unrefreshed Cognitive symptoms For each of the three symptoms above, indicate the level of severity over the past week using the following scale: 0=no problem 1=slight or mild problems, generally mild or intermittent 2=moderate, considerable problems, often present and/or at a moderate level 3=severe: pervasive, continuous, life-disturbing problems The SSS score is the sum of the severity scores of the three symptoms (fatigue, waking unrefreshed, and cognitive symptoms) (0∼9), plus the sum (0∼3) of the number of the following symptoms the patient has been bothered by that occurred during the previous 6 months: 1.Headaches (0∼1) 2. Pain or cramps in lower abdomen (0∼1) 3. Depression (0∼1). The final symptom severity score is between 0 and 12 The fibromyalgia severity scale is the sum of the WPI and SSS

  Within 1 month of applying to the outpatient clinic

Secondary Outcomes (4)

• Fibromyalgia Impact Questionnaire

  Within 1 month of applying to the outpatient clinic

• Beck Anxiety Inventory

  Within 1 month of applying to the outpatient clinic

• Beck Depression Inventory

  Within 1 month of applying to the outpatient clinic

• Short Form- 36 (SF-36)

  Within 1 month of applying to the outpatient clinic

Study Arms (2)

Patient group

Volunteer men and women diagnosed with fibromyalgia to ACR (American College of Rheumatology) 2016 criteria between the ages of 18 and 50 who applied to our clinic will be included in our study

Diagnostic Test: Fibromyalgia study form; Diagnostic Test: Pulmonary function test; Diagnostic Test: Ultrasonographic Diaphragm Thickness Measurement

Control group

Healthy,volunteer men and women between the ages of 18-50 who applied to our clinic will be included in our study

Diagnostic Test: Fibromyalgia study form; Diagnostic Test: Pulmonary function test; Diagnostic Test: Ultrasonographic Diaphragm Thickness Measurement

Interventions

Fibromyalgia study form DIAGNOSTIC_TEST

Fibromyalgia study form, consisting of clinical measurement, Fibromyalgia impact questionnaire (FIQ), Beck Anxiety Questionnaire and Beck Depression Questionnaire, Short-Form (SF)-36, who applied to the outpatient clinic with fibromyalgia will be filled in detail.

Control group; Patient group

Pulmonary function test DIAGNOSTIC_TEST

Pulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange. This information can help your healthcare provider diagnose and decide the treatment of certain lung disorders. The investigators will use handheld spirometry device for measurement. Three measurements will be made. In these three measurements; FEV1(Forced Expiratory Volume In One Second)(L), FEV1 (%predicted), FVC (Forced Vital Capacity) (L), FVC (%predicted), FEV1/FVC (%) and FEV1/FVC (%predicted) will be evaluated. The arithmetic average of the results of these three measurements will be taken.

Also known as: Spirometry function test

Control group; Patient group

Ultrasonographic Diaphragm Thickness Measurement DIAGNOSTIC_TEST

Diaphragm thickness (millimeter-mm) will be measured in the supine position with a 6-14 Mhz lineer, conventional ultrasound probe (Mindray DC-8, Shenzen Mindray Bio-Medical Electronics CO. LTD.,P.R. China) at the end of inspiration and expiration from the intercostal space on the anterior axillary line. The measurements will be evaluated by making three measurements from the right 8-9. intercostal space where the diaphragm is best visualized. End-expiratory (Forced residual capacity-FRC) (millimeter-mm), end-inspiratory (Total Lung Capacity) (millimeter-mm) and thickening rate (%) (thickness TLC / thickness FRC) will be evaluated three times and the arithmetic average of these three measurements will be taken.

Control group; Patient group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

It will consist of participants with fibromyalgia patients, according to the 2016 ACR (American College of Rheumatology) diagnostic criteria, who apply to the Physical Medicine and Rehabilitation Clinic of the University of Health Sciences Gaziosmanpasa Training and Research Hospital within the study date ranges, meet the inclusion and exclusion criteria and voluntarily agree to participate in the research. Healthy individuals identical in age and gender will be included in the study as a control group. Demographic information (Fibromyalgia study form, consisting of clinical measurement, Fibromyalgia impact questionnaire (FIQ), Beck Anxiety Questionnaire and Beck Depression Questionnaire, Short-Form (SF)-36, ) of all individuals involved in the recruitment will be collected.

You may qualify if:

• Patients diagnosed with fibromyalgia according to the 2016 ACR (American College of Rheumatology) diagnostic criteria without any comorbidities (such as liver, kidney failure, DM, rheumatic disease)
• Patients who underwent Pulmonary Function Test (PFT)
• Patients without pulmonary disease
• years old women and men

You may not qualify if:

• Congenital spinal, costal and diaphragmatic anomalies neuromuscular disease
• Respiratory system diseases that affect lung functions
• Patients who cannot cooperate with spirometry.
• Having surgery to the chest wall or spine
• Those with BMI \> 25
• Those with liver, kidney failure, DM, rheumatic disease, neurological disease
• Individuals \< 18 years and \> 50 years old

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Deniz Oke

Istanbul, Gaziosmanpasa, 34255, Turkey (Türkiye)

Location

Related Publications (6)

• Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.

  PMID: 20461783 RESULT

• Sarzi-Puttini P, Giorgi V, Atzeni F, Gorla R, Kosek E, Choy EH, Bazzichi L, Hauser W, Ablin JN, Aloush V, Buskila D, Amital H, Da Silva JAP, Perrot S, Morlion B, Polati E, Schweiger V, Coaccioli S, Varrassi G, Di Franco M, Torta R, Oien Forseth KM, Mannerkorpi K, Salaffi F, Di Carlo M, Cassisi G, Batticciotto A. Fibromyalgia position paper. Clin Exp Rheumatol. 2021 May-Jun;39 Suppl 130(3):186-193. doi: 10.55563/clinexprheumatol/i19pig. Epub 2021 May 13.

  PMID: 34001303 RESULT

• Alciati A, Nucera V, Masala IF, Giallanza M, La Corte L, Giorgi V, Sarzi-Puttini P, Atzeni F. One year in review 2021: fibromyalgia. Clin Exp Rheumatol. 2021 May-Jun;39 Suppl 130(3):3-12. doi: 10.55563/clinexprheumatol/gz4i3i. Epub 2021 May 13.

  PMID: 34001307 RESULT

• Ortiz-Rubio A, Torres-Sanchez I, Cabrera-Martos I, Lopez-Lopez L, Rodriguez-Torres J, Granados-Santiago M, Valenza MC. Respiratory disturbances in fibromyalgia: A systematic review and meta-analysis of case control studies. Expert Rev Respir Med. 2021 Sep;15(9):1217-1227. doi: 10.1080/17476348.2021.1918547. Epub 2021 Apr 26.

  PMID: 33857393 RESULT

• Tomas-Carus P, Biehl-Printes C, Del Pozo-Cruz J, Parraca JA, Folgado H, Perez-Sousa MA. Effects of respiratory muscle training on respiratory efficiency and health-related quality of life in sedentary women with fibromyalgia: a randomised controlled trial. Clin Exp Rheumatol. 2022 Jun;40(6):1119-1126. doi: 10.55563/clinexprheumatol/0v55nh. Epub 2022 Jun 22.

  PMID: 35748715 RESULT

• Noda Y, Sekiguchi K, Kohara N, Kanda F, Toda T. Ultrasonographic diaphragm thickness correlates with compound muscle action potential amplitude and forced vital capacity. Muscle Nerve. 2016 Apr;53(4):522-7. doi: 10.1002/mus.24902. Epub 2015 Oct 10.

  PMID: 26357011 RESULT

MeSH Terms

Conditions

Fibromyalgia; Anxiety Disorders; Depression

Interventions

Respiratory Function Tests

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Betul Ciftci, MD,Associate Professor

  Kirklareli University Faculty of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: May 2, 2024
• Study Start: December 15, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)